CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green recalled
Intersurgical is recalling One-Piece Guedel Airway, size 000, ISO 3.5, Light Green, distributed nationwide in the US. The recall was initiated on 15 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2953-2026
- FDA event ID
- 99284
- Recalling firm
- Intersurgical, East Syracuse, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jun 2026
- FDA classified
- 14 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Jun 2026 | Recall initiated by company | |
| 14 Aug 2026 | Classified by FDA | +60 days |
| 26 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices could potentially be occluded or partially occluded.
Product as listed by the FDA
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Where it was distributed
US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
Questions about this recall
Why was it recalled?
Devices could potentially be occluded or partially occluded.
Which lots are affected?
REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.
Where was it sold?
US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99284| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | One-Piece Guedel Airway, size 00, ISO 5.0, Blue recalled | Intersurgical | Other | Nationwide |
More recalls from Intersurgical
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | One-Piece Guedel Airway, size 00, ISO 5.0, Blue recalled | Intersurgical | Other | Nationwide |
| Device | CLASS II | One-piece Guedel airway, size 3, ISO 9.0, yellow recalled | Intersurgical | Other | 10 states |
| Device | CLASS II | One-piece Guedel airway, size 2, ISO 8.0, green recalled | Intersurgical | Other | 10 states |
| Device | CLASS I | i-view video laryngoscope recalled by Intersurgical | Intersurgical | Other | 17 states |
| Device | CLASS II | Solus Standard, laryngeal mask airway, size 3, small adult recalled | Intersurgical | Other | OH, TN, TX |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |